ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls— 510(k) K243575

Substantially Equivalent

Biokit, S.A.

FDA 510(k) clearance K243575 for ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls, Substantially Equivalent on 2025-02-12. Applicant: Biokit, S.A..

Clearance details

Applicant: Biokit, S.A.
Product code: Code MYF
Advisory panel: Microbiology
Date received: 2024-11-19
Decision date: 2025-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lliçà DAmunt, Barcelona, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code MYF

product code MYF

Injury: 316
Other: 1
Total: 317

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.